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October 2024
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Media Release
Novartis Scemblix® FDA approved in newly diagnosed CML, offering superior efficacy, and favorable safety and tolerability profile
Scemblix, a new first-line option for adults with CML, is first to show superior efficacy and favorable safety and tolerability profile in a Phase III trial vs. all standard of care (SoC)… -
Media Release
Novartis oral Fabhalta® (iptacopan) sustained clinically meaningful results at one year in Phase III C3 glomerulopathy (C3G) trial
New APPEAR-C3G data show Fabhalta sustained proteinuria reduction at 12 months1Upon Fabhalta initiation, improvement observed in estimated glomerular filtration rate (eGFR) slope – a key measure of… -
Media Release
Novartis ribociclib (Kisqali®) recognized as Category 1 preferred breast cancer adjuvant treatment by NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)
Ribociclib (Kisqali) plus aromatase inhibitor (AI) recommended for HR+/HER2- early breast cancer (EBC) node-positive and high-risk node-negative patients, as studied in the NATALEE trial and… -
Media Release
Novartis receives positive CHMP opinion for Kisqali® to help reduce risk of recurrence in people with HR+/HER2- early breast cancer
If approved, patients in Europe with stage II or III HR+/HER2- early breast cancer (EBC) at high risk of recurrence, including those with node-negative disease, will be eligible for adjuvant…
September 2024
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Media Release
New Novartis data in relapsing MS reinforce benefits of Kesimpta® for first-line and switch patients
Nearly 90% of first-line Kesimpta patients had no disability progression independent of relapse activity (PIRA) for up to six years in an analysis of open-label ALITHIOS extension study1 More than… -
Media Release
FDA approves Novartis Kisqali® to reduce risk of recurrence in people with HR+/HER2- early breast cancer
Broad indication in HR+/HER2- stage II and III early breast cancer (EBC) at high risk of recurrence approximately doubles population eligible for CDK4/6 inhibitor adjuvant therapy1,2 … -
Media Release
Novartis Kisqali® shows deepening benefit in new analysis, reducing the risk of recurrence by 28.5% in a broad population of patients with early breast cancer
Invasive disease-free survival benefit continued to increase after completion of the three-year treatment period across all patient subgroups, including those with node-negative disease1 … -
Media Release
Novartis begins construction of two new radioligand therapy facilities in the US, expanding its world-class RLT manufacturing and supply network
Indianapolis site expansion will establish in-house production of isotopes critical for production of radioligand therapies (RLTs) for cancer treatment New facility in California will be…
August 2024
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Negative impact of the IRA on patient access to innovative treatments
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Statement
Novartis statement on Maximum Fair Price for Entresto
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Media Release
Novartis receives FDA accelerated approval for Fabhalta® (iptacopan), the first and only complement inhibitor for the reduction of proteinuria in primary IgA nephropathy (IgAN)
Fabhalta achieved a 44% proteinuria reduction from baseline in Phase III APPLAUSE-IgAN interim analysis, compared with 9% in placebo arm, demonstrating a clinically meaningful reduction of 38% vs.…
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